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Asahi Confianza Pro 8-20 Guide Wire

FDA 510(k)

Class II (US FDA 510(k))

510(k) K211898

by Asahi Intecc Co., Ltd.

Identifiers

510(k) Number
K211898 FDA 510(k)
FDA Product Code
DQX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1330 FDA 510(k)
Regulation Number
870.1330 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Asahi Confianza Pro 8-20 Guide Wire is a tapered coronary guide wire designed for percutaneous coronary intervention (PCI). It is intended for crossing complex lesions, including chronic total occlusions (CTOs), heavy calcification, or dense fibrous tissues, facilitating wire advancement through challenging vascular obstructions.

This guide wire is supplied as a single-use, non-sterile device and features a 20 cm hydrophilic coating with an uncoated distal tip for enhanced maneuverability. It is classified under product code DQX and has received FDA 510(k) clearance through a special review process by the Cardiovascular Advisory Committee. Storage and handling should follow sterile medical device protocols prior to use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CONFIANZA® Pro 8-20 | Asahi Intecc Medical, CONFIANZA® Pro Series | Asahi Intecc Medical, ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20 (K211898) — FDA 510 (k ..., PDF December 8, 2021 Asahi Intecc Co., Ltd.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Asahi Intecc Co., Ltd.

Sources (1)

  • FDA 510(k) K211898 24 fields · synced Sep 19, 2026